BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 21845391 · Received April 15, 2025

    Report

    Report Number
    3013756811-2025-74106
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 15, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE MULTIPLE ALTITUDE ALARMS. REPORTEDLY, AN OBSTRUCTION WAS BLOCKING THE SPEAKER HOLES. AFTER REMOVING THE OBSTRUCTION FROM THE SPEAKER HOLES AND CHANGING THE CARTRIDGE THE ALARMS CLEARED. THE CUSTOMER'S BLOOD GLUCOSE WAS 251 - 390 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349858 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60610220

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female INSULIN TYPE: HUMALOG